European Standard Operating Procedure (SOP) Manual, Edition 1.0, 2007
2. An effective recall procedure shall be in place, including a description of the responsibilities and actions to be taken. This shall include notification to the competent authority.
3. Actions shall be taken within pre-defined periods of time and shall include tracing all relevant blood components and, where applicable, shall include trace-back. The purpose of the investigation is to identify any donor who might have contributed to causing the transfusion reaction and to retrieve available blood components from that donor, as well as to notify consignees and recipients of components collected from the same donor in the event that they might have been put at risk.
9.4. Corrective and preventive actions
1. A system to ensure corrective and preventive actions on blood component non-conformity and quality problems shall be in place.
2. Data shall be routinely analysed to identify quality problems that may require corrective action or to identify unfavourable trends that may require preventive action.
3. All errors and accidents shall be documented and investigated in order to identify system problems for correction.
Section E: Documentation
The documentation of procedures and records is essential to a quality assurance system.
It ensures that work performed is standardised, and that there is a traceability of all steps in the collection, manufacturing, testing, release/issuing, storage and distribution of blood components.
All records shall be kept for a minimum of 30 years (Directive 2002/98/EC).
Additional requirements are defined by Directive 2005/62/EC, Annex, Article 5 as follows:
5. Documentation
1). Documents setting out specifications, procedures and records covering each activity performed by the blood establishment shall be in place and kept up to date.
2) Records shall be legible and may be handwritten, transferred to another medium such as microfilm or documented in a computerised system.
3) All significant changes to documents shall be acted upon promptly and shall be reviewed, dated and signed by a person authorised to perform this task.
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